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Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
ropivacaine 0.2%, 50 mL
normal saline
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • total bilateral knee arthroplasty

Exclusion Criteria:

  • immunological diseases
  • treatment with opioids or steroids
  • allergy to any drugs administered

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active

placebo

Arm Description

subcutaneous wound infiltration with 50 mL ropivacaine 0.2%

subcutaneous wound infiltration with 50 mL saline

Outcomes

Primary Outcome Measures

Postoperative pain

Secondary Outcome Measures

Full Information

First Posted
June 23, 2009
Last Updated
June 23, 2009
Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00927225
Brief Title
Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic
Official Title
Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Local infiltration analgesia is effective in total knee arthroplasty for postoperative pain management, but the efficacy of subcutaneous wound infiltration has not been evaluated. This study aims at evaluating the efficacy of subcutaneous wound infiltration in total knee arthroplasty in 16 patients undergoing bilateral knee arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active
Arm Type
Active Comparator
Arm Description
subcutaneous wound infiltration with 50 mL ropivacaine 0.2%
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous wound infiltration with 50 mL saline
Intervention Type
Drug
Intervention Name(s)
ropivacaine 0.2%, 50 mL
Intervention Type
Drug
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
Postoperative pain
Time Frame
1-6 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: total bilateral knee arthroplasty Exclusion Criteria: immunological diseases treatment with opioids or steroids allergy to any drugs administered
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
20055763
Citation
Andersen LO, Husted H, Kristensen BB, Otte KS, Gaarn-Larsen L, Kehlet H. Analgesic efficacy of subcutaneous local anaesthetic wound infiltration in bilateral knee arthroplasty: a randomised, placebo-controlled, double-blind trial. Acta Anaesthesiol Scand. 2010 May;54(5):543-8. doi: 10.1111/j.1399-6576.2009.02196.x. Epub 2010 Jan 6.
Results Reference
derived

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Local Infiltration Analgesia in Bilateral Knee Arthroplasty - Efficacy of Subcutaneous Wound Infiltration With Local Anesthetic

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